MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-02-20 for GENIUM X3 3B5-2=S manufactured by Otto Bock Healthcare Products Gmbh.
[136590903]
Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the occurred event.
Patient Sequence No: 1, Text Type: N, H10
[136590904]
During the service, adjustments with the genium x3 a fall occured. As a result of the fall, a fracture in the right ankle joint occurred which had to be treated surgically. According to the user, she went on level gravel surface, the knee joint suddenly and unexpectedly blocked. By blocking of the joint, it came immediately to the fall. The knee joint was installed according to the manufacturer's instructions and the parameters corresponded to those of the user's knee joint in service. Statics, dynamics and the function of the prosthesis were checked before delivery of the service joint and were alright.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615892-2019-00003 |
| MDR Report Key | 8353297 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-02-20 |
| Date of Report | 2019-02-20 |
| Date of Event | 2019-01-14 |
| Date Mfgr Received | 2019-01-22 |
| Device Manufacturer Date | 2017-01-11 |
| Date Added to Maude | 2019-02-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. REINHARD WOLKERSTORFER |
| Manufacturer Street | BREHMSTRASSE 16 |
| Manufacturer City | VIENNA, 1110 |
| Manufacturer Country | AU |
| Manufacturer Postal | 1110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENIUM X3 |
| Generic Name | EXTERNAL ABOVE KNEE PROSTHESIS |
| Product Code | ISY |
| Date Received | 2019-02-20 |
| Returned To Mfg | 2019-01-30 |
| Model Number | 3B5-2=S |
| Catalog Number | 3B5-2=S |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTO BOCK HEALTHCARE PRODUCTS GMBH |
| Manufacturer Address | BREHMSTRASSE 16 VIENNA, 1110 AU 1110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-02-20 |